Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ChiCTR |
Last refreshed on:
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18 April 2017 |
Main ID: |
ChiCTR-IPR-15006959 |
Date of registration:
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2015-07-22 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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EFFECT OF VITAMIN C ON PHARMACOKINETICS OF GANODERIC ACIDS A AND F AFTER ORAL ADMINISTRATION OF LING ZHI PREPARATION IN HEALTHY THAI MALE VOLUNTEERS
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Scientific title:
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EFFECT OF VITAMIN C ON PHARMACOKINETICS OF GANODERIC ACIDS A AND F AFTER ORAL ADMINISTRATION OF LING ZHI PREPARATION IN HEALTHY THAI MALE VOLUNTEERS |
Date of first enrolment:
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2014-09-01 |
Target sample size:
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healthy Thai male volunteers:12; |
Recruitment status: |
Pending |
URL:
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http://www.chictr.org.cn/showproj.aspx?proj=11483 |
Study type:
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Interventional study |
Study design:
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Randomized cross-over control
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Phase:
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Pilot study
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Assoc. Prof. Dr. Supanimit Teekachunhatean
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Address:
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Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Intawaroros Rd., Tambon Sriphum, Chiang Mai, Thailand
50200
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Telephone:
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+08 8 6491955 |
Email:
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doctormit@hotmail.com |
Affiliation:
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Name:
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Patcharanee Tawasri
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Address:
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Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Intawaroros Rd., Tambon Sriphum, Chiang Mai, Thailand
50200
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Telephone:
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+08 4 2224151 |
Email:
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ii_sikrit@hotmail.com |
Affiliation:
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Chiang Mai University |
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Key inclusion & exclusion criteria
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Inclusion criteria: Twelve healthy Thai male subjects aged between 18-40 y and body mass index (BMI) within 18.5-24.9 kg/m2 will be enrolled in this study. They will be considered healthy on the basis of their medical history, physical examination and vital signs. The results of routine laboratory tests including complete blood count (CBC), liver function test (LFT), blood urea nitrogen (BUN) and creatinine (Cr) and must be within normal limit to exclude subjects with hematological diseases, abnormal liver and renal functions
Exclusion criteria: Hypersensitivity to Ling Zhi or vitamin c, chronic renal, liver, neurological, pulmonary or cardiovascular diseases including malignancy, history of kidney stones, glucose-6-phosphate dehydrogenase deficiency, bleeding disorders or family history of iron overload/hemochromatosis, recent cigarette smoking within the previous 3 months, alcohol or substance abuse, use of any Ling Zhi preparation or vitamin C or other medications (except acetaminophen) within the previous 1 month.
Age minimum:
18
Age maximum:
40
Gender:
Male
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Health Condition(s) or Problem(s) studied
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HEALTHY THAI MALE VOLUNTEERS
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Intervention(s)
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healthy Thai male volunteers:Ling zhi;
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Primary Outcome(s)
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blood level ganoderic acid A and F;
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Source(s) of Monetary Support
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Faculty of Medicine, Chiang Mai University
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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